Senior System Engineer招聘_费森尤斯医药研发（上海）有限公司最新招聘信息-猎才医药网

Senior System Engineer 上海

费森尤斯医药研发（上海）有限公司

月薪： 1-2万/月

5-7年经验
本科
招1人
12-06 发布

职位描述

职位描述： 1) Main tasks:1.Transfer marketing product requirements and regulatory standard into technical requirements, design and document the system architecture, including review and alignment with key stakeholders2.Develop technical solution for specific requirements or features, lead the implementation of possible technical solutions and evaluate them with reasonable Matrix methodologies.3.Coordinate the development activities among different functions (R&D, Verification, R&A, purchase, etc.), such as design review, system integration, project planning and so on.4.Be one of the Cross Functional Team members within the R&D projects, provide routine status to project team and get the feedback5.Support relevant product registration activities and provide help as necessary2) Secondary tasks:1.Build up system know how on dialysis machines and the application development and provide it to other functions in the organization, including solid technological know-how, setup and maintenance, and medical scientific background2.Develop innovative ideas to fulfil the unmet needs from the market3.Assure compliance to corporate policies and local standards operating procedures as well as domestic and international standards3) Miscellaneous tasks:Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.1.Other tasks assigned by the supervisor1) Required training and education:Master degree or above in engineering or science; or Bachelor’s with equivalent plus more than 6 years product life cycle experience with demonstrated results to do system design of complex professional instrument, medical device will be a plus2) Required professional experience (in years):1.6 years or more related experience in Medical device industry3) Important personal qualities:1.Able to work with people with different cultural and education background2.Self-Initiative and able to work under certain pressure3.Good communication skills4.Team work spirits4) Other specialized knowledge:a) Technical knowledge1.Proven education regarding Master or Bachelor in Systems, Mechanical, Electrical, Computer Science, Physics or Biomedical Engineering2.Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, bothdomestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, CFDA3.Demonstrated experience in product development for complex professional instrument. Medical device is preferred.4.Capability of System Modelling simulation5.Demonstrated experience in product requirements break-down into systems, subsystems, modules and/or cross functions.6.Demonstrated expertise in applying DFx (manufacturability, assembly, serviceability, safety, cost) knowledge to system & sub-systems designs in mechanical, electronics, software/firmware.b) Languages1.Good written and verbal communication skills in Englishc) IT skills1.Good word, excel and PPT tool2.Skills in product requirement management tools, like DOORs, Polarion, etcd) Product knowledge1.Experience in Medical device development and relevant regulatory standard, system architecture, working principle, safety design, etc2.Experience in other professional diagnosis instrument and relevant regulatory standard, system architecture, working principle, safety design, etc3.Good understand of the operation environment of the product being developed and its market situation5 ) Special personal requirements:1.Excellent communication and documentation skills2.Excellent ethic with strong ability to work with cross functional/sites teams3.Being self-initiative and have strong sense of product quality and responsibilities4.Good English skills both in verbal and writing5.Being flexible for abroad training and travelling6.Being innovative and open to the new technologies 职能类别：医疗器械研发